DOLPHIN-VIVO: Diagnosis Of LymPHoma IN Vivo (Ex Vivo Phase) (DOLPHIN-VIVO)

Diagnosis Of Lymphoma In Vivo Using Vibrational Spectroscopy (Ex Vivo Phase)

Lymphoma diagnosis often involves removal and biopsy of one or more lymph nodes. Many (around half) of these diagnostic procedures show that no cancer is present, hence unnecessary removal results in numerous side effects and complications. The procedure is also highly invasive.

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when a low power laser is shone on to it. The investigators intend to use this technique, known as "Raman Spectroscopy" (RS) to tell if tissue in the node is cancerous or healthy. By combining RS with a fine needle, the technique can target tissues below the skin with minimal invasion. Our needle will provide the clinician with instant diagnosis without the delay and cost of a laboratory analysis by pathologists.

The investigators have designed a probe that slides through a fine needle, guided by ultrasound, to the lymph node. The space between the two needles provides space for cell aspirate.

The investigators propose to measure spectra from excess lymph node biopsy samples taken during standard routine diagnostic biopsy.

The investigators are also interested to see if they can successfully extract a fine needle aspiration (FNA) biopsy sample using the device, as well as record a RS measurement. If successful this would ease clinical adoption as the study could run in parallel with existing standard routine clinical practice, using just one device.

This study will evaluate the new device on half a lymph node that will be excised and snap-frozen during a routine surgical biopsy, to gather data for submission of approvals for an in-vivo study to follow.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Head and Neck Cancer
• Intervention / Treatment: Diagnostic test: spectroscopic measurement; Diagnostic test: FNA biopsy; Diagnostic test: histopathology and cytology

Detailed Description

Surplus lymph node tissue collected from patients undergoing routine surgical treatment for head & neck disease will be investigated using vibrational spectroscopy.

The project will develop a combined FNA/Raman spectroscopy needle probe. This study will evaluate this device on excised lymph node tissue to gather data for submission of approvals for an in-vivo study to follow. Raman & FTIR (fourier transform infrared) spectra will be correlated with routine histopathology results using multivariate analysis methods. Cytology samples taken using the device will be compared with histopathology results.

Aims

To demonstrate that the FNA/Raman spectroscopy probe device, developed as part of this project, can:

Safely perform measurement of Raman spectra on excised lymph node tissue Safely perform FNA (fine needle aspiration) biopsies on excised lymph node tissue To evaluate the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes.

To develop the investigators understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

Objectives To test a new combined FNA and spectroscopic device on ex vivo tissue in preparation for an in vivo study.

Outcome

Primary Outcome Measures The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.

Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma & malignant nodes from benign nodes.

Secondary Outcome Measures Evaluation of the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes. To develop the investigators understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).

Evaluation of the performance of a Raman needle probe to measure head & neck lymph nodes (ergonomic design, ease of use etc.).

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Antony Walsh; Phone Number: 01392 726621; Email: A.walsh3@exeter.ac.uk

Study Locations

• United Kingdom
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Recruiting
      • Gloucestershire Hospitals NHS Foundation Trust
      • Contact: Julia Hall; Phone Number: 03004225466; Email: julia.hall9@nhs.net
      • Principal Investigator: Charlie Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgical head & neck lymph node biopsy within Gloucestershire Hospitals NHS Foundation Trust Patients with a lump in their head or neck are sometimes referred by their GP for a biopsy. This often first involves taking a small sample of cells with a fine needle, guided by ultrasound, called a Fine Needle Aspiration (FNA) biopsy. If the result from this FNA biopsy is inconclusive, then they are often further referred for a surgical biopsy. Gloucestershire Hospitals NHS Foundation Trust is a tertiary referral centre for surgical head and neck biopsies.

Description

Inclusion Criteria:

• Patients undergoing biopsy or excision of lymph nodes as part of their routine clinical care within Gloucestershire Hospitals NHS Foundation Trust.
• Patients undergoing lymphadenectomy as part of routine treatment

Exclusion Criteria:

• Patients unable to consent to the study due to communication difficulties
• Patients unable to consent to the study due to lack of capacity

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-hodgkin lymphoma; patients diagnosed with non-hodgkin lymphoma	Diagnostic test: spectroscopic measurement; measurement of the tissue with spectroscopy; Other Names: raman; infra red; Diagnostic test: FNA biopsy; a fine needle aspiration (FNA) biopsy will be taken; Other Names: fine needle aspiration biopsy; Diagnostic test: histopathology and cytology; Histopathology and cytology will be performed on the samples
hodgkin lymphoma; patients diagnosed with hodgkin lymphoma	Diagnostic test: spectroscopic measurement; measurement of the tissue with spectroscopy; Other Names: raman; infra red; Diagnostic test: FNA biopsy; a fine needle aspiration (FNA) biopsy will be taken; Other Names: fine needle aspiration biopsy; Diagnostic test: histopathology and cytology; Histopathology and cytology will be performed on the samples
squamous cell carcinoma; patients diagnosed with squamous cell carcinoma	Diagnostic test: spectroscopic measurement; measurement of the tissue with spectroscopy; Other Names: raman; infra red; Diagnostic test: FNA biopsy; a fine needle aspiration (FNA) biopsy will be taken; Other Names: fine needle aspiration biopsy; Diagnostic test: histopathology and cytology; Histopathology and cytology will be performed on the samples
reactive; patients diagnosed with a reactive (non-cancerous) lymph node	Diagnostic test: spectroscopic measurement; measurement of the tissue with spectroscopy; Other Names: raman; infra red; Diagnostic test: FNA biopsy; a fine needle aspiration (FNA) biopsy will be taken; Other Names: fine needle aspiration biopsy; Diagnostic test: histopathology and cytology; Histopathology and cytology will be performed on the samples
other; none of the above. Other cancer and non-cancer conditions	Diagnostic test: spectroscopic measurement; measurement of the tissue with spectroscopy; Other Names: raman; infra red; Diagnostic test: FNA biopsy; a fine needle aspiration (FNA) biopsy will be taken; Other Names: fine needle aspiration biopsy; Diagnostic test: histopathology and cytology; Histopathology and cytology will be performed on the samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe spectroscopic measurement	The FNA/Raman spectroscopy probe device can be used safely on excised lymph nodes to measure tissue spectra and collect FNA biopsies.	3 years
Diagnostic discrimination	Diagnostic performance of vibrational spectroscopy for differentiation of lymphoma & malignant nodes from benign nodes	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Performance evaluation	Evaluation of the performance of a Raman needle probe to detect lymphoma & malignancy in excised head & neck lymph nodes and differentiate from benign nodes	3 years
Understanding of Raman on lymph nodes	To develop our understanding of vibrational spectroscopy signal characteristics in head & neck lymph nodes (through Raman & FTIR mapping measurements of tissue sections).	3 years
General Performance evaluation	Evaluation of the performance of a Raman needle probe to measure head & neck lymph nodes (ergonomic design, ease of use etc.)	3 years

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: University of Bristol; Gloucestershire Hospitals NHS Foundation Trust
• Investigators: Study Director: Nick Stone, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lymphoma; Raman
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 1819/31; II-LB-1117-20002 (Other Grant/Funding Number: NIHR); 258155 (Registry Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Unique study number and MRN (medical records number) (hospital number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No